DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election in the reply filed on 10 September 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ “species” election of: “fatty acid ethyl ester of omega-3 fatty acids” as species of “Extractant” is not compliant as it is not drawn to a specific compound-therefore the Examiner has withdrawn the species election just for the genus “extractant” and has found prior art against “eicosapentaenoic acid” (“EPA”) as a “fatty acid ethyl ester” according to claims 22-23 . However, the Examiner has maintained the Election of Species Requirement for “component” since Applicants have provided a compliant species election of “cannabinoid” as species of “component”. This elected species has prior art.
Therefore, per Markush Search practice, the Markush search will not be extended unnecessarily to additional species of “component” in this Office Action.
Claims 21-33, 36-41, and 44-51 read on the elected species.
Claims 34-35 and 42-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 September 2025.
Current Status of 18/022,869
This Office Action is responsive to the amended claims of 23 February 2023.
New claims 21-33, 36-41, and 44-51 have been examined on the merits.
Priority
The effective filing date is 26 August 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 February 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 22 is objected to as it contains “comprises or is”. The “or is” is interpreted as redundant since “comprises” does the “heavy lifting” for claim transition wording. Please delete the “or is” to render moot this objection. Claim 23 is similarly objected to as it refers back to claim 22 but does not remedy the rationale underpinning the basis for objecting to claim 22.
Furthermore, claim 50, containing “comprises or is” is similarly objected to.
Claim 38 is objected to as it contains “substance mixture or/and the fatty acid methyl ester”. The way this is written makes the reader wonder if Applicants consider the “fatty acid methyl ester” to be a part of the “substance mixture”. If it is, then please revise to: -- wherein the fatty acid ethyl ester or/and the fatty acid methyl ester contained in the substance mixture
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-33, 36-41, and 44-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomena without significantly more. The claim(s) recite(s): (1) a method of extracting naturally occurring compound(s) from naturally occurring plants by using naturally occurring fatty acid ester solvents such as “eicosapentaenoic acid” (“EPA”); and also are drawn to: (2) a combination (“substance mixture”) comprising the fatty acid ester solvent (“extractant”) and extracted naturally occurring compounds. These judicial exceptions (JE) are not integrated into a practical application because the claims only add insignificant extra-solution activities (the “extractant” “fatty acid esters”) and do not impose a meaningful limit on the JE, such that the claims are only mere drafting efforts designed to monopolize the exceptions. Furthermore, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims represent well-understood, routine, and conventional (“WURC”) extraction skills/steps/components routinely utilized in cannabinoid and other plant material extraction processes by individuals and laboratories world-wide.
Step 1: Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes, the broadest reasonable interpretation (BRI) of claims 21-33, 36-41, and 44 are drawn to a process of extracting a naturally occurring compound from a naturally occurring source (ie., a plant) using a naturally occurring fatty acid ethyl ester or fatty acid methyl ester (the “extractant”).
Yes, the BRI of claims 45-51 are drawn to a composition of matter comprising a mixture (the “substance mixture”) containing an extracted substance (naturally occurring) extracted from a naturally occurring plant material wherein the substance mixture comprises naturally occurring fatty acid ethyl ester or fatty acid methyl ester.
Revised Step 2A:
Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
The BRI of the claims 21-33, 36-41, and 44-51 are all drawn to natural phenomenon:
The BRI of claims 21-33, 36-41, and 44 are drawn to a process of extracting a naturally occurring compound from a naturally occurring source (ie., a plant) using a naturally occurring fatty acid ethyl ester or fatty acid methyl ester (the “extractant”). The method of extraction per se does not serve as a “markedly different characteristic” to distinguish these method claims from naturally occurring phenomena; put another way, the BRI of the method is just drawn to using naturally occurring plants, and extracting naturally occurring compounds from the naturally occurring plants utilizing naturally occurring fatty acid esters.
The BRI of claims 45-51 are drawn to a composition of matter comprising a mixture (the “substance mixture”) containing an extracted substance (naturally occurring) extracted from a naturally occurring plant material wherein the substance mixture comprises naturally occurring fatty acid ethyl ester or fatty acid methyl ester. These claims do not serve as a “markedly different characteristic” since the BRI of these claims are just drawn to the resultant extracted “substance mixture” from the method claims, above, comprising the naturally occurring fatty acid esters (“extractant”) and naturally occurring extracted compounds from the naturally occurring plants.
All the claims 21-33, 36-41, and 44-51 are drawn to natural phenomenon hence each of these claims recite a judicial exception (JE). The claims 21-33, 36-41, and 44-51 do not recite any markedly different characteristics that would distinguish these claims from naturally occurring phenomena.
Prong 2: Does the claim recite additional elements that integrate the JE into a practical application?
No, the BRI of claims 21-33, 36-41, and 44-51 contain no additional elements that would integrate the JE into practical applications. Prong 2 requires an additional element or combination of additional elements to use the JE in a manner that imposes a meaningful limit on the JE, such that the claims are more than mere drafting efforts designed to monopolize the exceptions.
The method claims and the composition of matter claims add insignificant extra-solution activities to the JE by reciting the fatty acid esters. Furthermore, the Specification and claims do not indicate these fatty acid esters cannot be naturally occurring - i.e., they are found in at least fish oil (see pages 1-3 of the enclosed reference FISH (“Eicosapentaenoic Acid (“EPA”) – Uses, Side Effects, and More.” WebMD. Available online: 22 June 2020, according to Internet Way Back Machine. Accessed 22 January 2026. Available from: < https:// https://web.archive.org/web/20200622235407/https:/www.webmd.com/vitamins/ai/ingredientmono-994/eicosapentaenoic-acid-epa > )).
Step 2B: Does the claim recite additional elements that amount to significantly more than the JE?
No, the BRI of the claims does not recite additional elements that amount to significantly more than the JE. The various dependent claims drawn to additional organic solvents, such as alcohols, and varying concentrations of fatty acid esters, at best, represent well-understood, routine, and conventional (“WURC”) extraction skills/steps/components routinely utilized in cannabinoid and other plant material extraction processes by individuals and laboratories world-wide.
Hence, the claims 21-33, 36-41, and 44-51 are NOT patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-33, 36-41, 44, and 49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 contains the phrase “in particular” followed by a limitation. The “in particular” renders the metes and bounds of claim 21 undefined (hence rendering claim 21 indefinite) since the artisan is not certain whether the limitation(s) following “in particular” are merely exemplary or are required limitations of the claim. Please delete “in particular” to render moot this rejection.
Claims 22-33, 36-41, and 44 are similarly rejected as indefinite since these claims refer back to claim 21 but do not remedy the rationale underpinning the basis for rejecting claim 21.
Claim 25 contains “preferably”, which renders the metes and bounds of claim 25 undefined (hence rendering claim 25 indefinite). The artisan does not know if the limitations following “preferably” are merely exemplary or are required limitations of the claim. Please delete “preferably” to render moot this rejection.
Claims 26-27 are similarly rejected as indefinite since these claims refer back to claim 25 but do not remedy the rationale underpinning the basis for rejecting claim 25.
Claim 33 recites the limitation “fatty acid ethyl”. There is insufficient antecedent basis for this limitation in the claim.
The limitation “fatty acid ethyl” in claim 33 renders the metes and bounds of claim 33 undefined (hence rendering claim 33 indefinite) since the artisan does not know where antecedent basis can be found for “fatty acid ethyl” within parent claims 21, 31, or 32. Perhaps Applicants really intend: -- fatty acid ethyl ester -- within claim 33?
Claim 38 recites the limitation “the substance mixture”. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the substance mixture” within claim 38 renders the metes and bounds of claim 38 undefined (hence rendering claim 38 indefinite) since the artisan does not know where antecedent basis can be found for “substance mixture” per se, within claim 21. Please consider making claim 38 depend from claim 37 (which contains “a substance mixture”), instead of claim 21 to render moot this rejection.
The word “including” within claim 39 renders the metes and bounds of claim 39 undefined (hence rendering claim 39 indefinite) since the artisan does not know if the limitations following “including” are merely exemplary or are required limitations of the claim. Claims 40-41 are similarly rejected as indefinite since these claims refer back to claim 39 and also contain “including” hence do not remedy the rationale underpinning the basis for rejecting claim 39.
Claim 44 is similarly rejected as indefinite since it contains “including”.
Please delete “including” from each of claims 39-41 and 44 to render moot this rejection.
The term “substantially” in claim 49 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Hence, the metes and bounds of claim 49 are undefined (hence rendering claim 49 indefinite) since the artisan does not know the standard by which to measure “substantially” within the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-28, 36-38, 45-47, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
NEPTUNE (WO 2020/028991 A1, provided by Applicants, and referenced in IDS of 23 February 2023).
The prior art reference NEPTUNE teaches a method for extraction, comprising using “eicosapentaenoic acid” (“EPA”) (the elected “fatty acid ethyl ester of omega-3 fatty acids” “extractant”) to dissolve a cannabinoid(s) (Applicants’ elected “component”) out of a plant material. This anticipates instant claims 21-23. The cannabinoid is bound within the EPA, thereby forming a “substance mixture” and anticipating instant claims 27-28 and 36-38 (see paragraphs [0005]-[0006] and [0009] and [00015] and [00022] and [00070] and [00076] and [00085]). This also anticipates instant claims 45-47 and 50.
Moreover, NEPTUNE anticipates further use of an additional organic solvent, namely the alcohols methanol and ethanol thereby anticipating instant claims 24-26 (paragraph [00037] and page 35).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-33, 36-41, and 44-51 are rejected under 35 U.S.C. 103 as being unpatentable over:
NEPTUNE (WO 2020/028991 A1, provided by Applicants, and referenced in IDS of 23 February 2023).
Determining the scope and contents of the prior art:
The prior art reference NEPTUNE teaches instant claims 21-28, 36-38, 45-47, and 50, see, supra.
The NEPTUNE prior art reference teaches varying concentrations of “eicosapentaenoic acid” (“EPA”) (this is species of “fatty acid ethyl ester” “extractant”), including 10%, 15%, etc. up to 95% EPA in the “substance mixture” (see paragraph [00090]). This helps teach instant claims 29-33, 39-41, 44, 48-49, and 51.
Ascertaining the differences between the prior art and the claims at issue:
The reference NEPTUNE does not explicitly teach the specific concentrations of claims 29-33, 39-41, 44, 48-49, and 51. Nevertheless, NEPTUNE does teach that the artisan has varied the concentrations of EPA (“extractant”/”lipid solvent”) during the normal course of practicing the prior art.
3. Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in using fatty acid ethyl (and methyl) esters (the “extractants”) as extractants to extract compound(s) out of plant material. The artisan also is knowledgeable in the routine optimization/experimentation needed to carryout the extraction process and when to vary the concentrations of extractant in the course of optimizing extraction.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness:
The concentrations of EPA extractants seen within claims 29-33, 39-41, 44, 48-49, and 51 is interpreted as “concentrations” that the artisan would be expected to routinely optimize. Hence, the artisan would find prima facie obvious the various claims drawn to different concentrations of fatty acid ethyl ester extractants.
The artisan would be expected to vary concentrations of fatty acid ester extractant in the normal course of optimizing extraction efficiency. The artisan would be motivated to vary concentrations of extractant fatty acid ethyl esters, such as EPA, in the normal course of experimentation to settle on the most efficacious and efficient extraction process. Proof that extractant concentrations are varied, and that varying extractant concentrations is routine, and hence obvious, can be seen within paragraph [00090] of NEPTUNE where the prior art reference discusses various exemplary concentrations of EPA (“extractant”/”liquid solvent”) envisaged by the prior art.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007). See MPEP 2144.05(II)(A). Thus, this teaches instant claims 21-33, 36-41, and 44-51.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625